CTD Module 1
1.11 Foreign regulatory information
Overview
This section of the Module 1 holds information regarding the foreign (overseas) regulatory status for the medicine and the supporting data for the dossier.
Summary of requirements
| Section | Description | Category 1/Category 2 | Category 3 | ||
|---|---|---|---|---|---|
| New registration | Variation | New registration | Variation | ||
| 1.11.1 | Foreign regulatory status | mandatory | mandatory | not required | not required |
| 1.11.2 | Foreign product information | mandatory | requirement defined by the regulatory activity | not required | not required |
| 1.11.3 | Data similarities and differences | mandatory | requirement defined by the regulatory activity | not required | not required |
| 1.11.4 | Foreign evaluation reports: | requirement defined by the regulatory activity | not required | ||
| Category 1 | requirement defined by the regulatory activity | requirement defined by the regulatory activity | |||
| Category 2 | mandatory | mandatory | |||
Module 1.11.1 Foreign regulatory status
When to include information about the foreign regulatory status
Include with all category 1 and category 2 regulatory activities.
How to prepare information about the foreign regulatory status
- Provide a list of countries in which a similar application has been submitted including:
- dates of submission (if available)
- the status of these regulatory activities
- List must include the status of similar regulatory activities in the following countries:
- European Union (if centralised procedure)
- the Netherlands, Sweden, and United Kingdom (if mutual recognition, decentralised, or national applications)
- United States of America
- Canada
- Switzerland
- New Zealand
- Singapore
- Include details of:
- approvals (with indications)
- deferrals (with reasons)
- withdrawals (with reasons)
- rejections (with reasons)
- For applications submitted to agencies in the European Union include:
- the type of application (centralised, mutual recognition, decentralised, or national)
- for centralised applications, the rapporteur and co-rapporteur
- for mutual recognition and decentralised applications, the reference member state.
Note:
If an application is rejected by overseas authorities during the Australian evaluation process, the applicant must immediately inform the TGA.
The format for providing information to the TGA on foreign regulatory status should be consistent whenever an update to the information is provided for a given submission.
Suggested format
Information on the foreign regulatory status of similar applications may be provided in tabular form, as shown below:
| Country/region | Submission date | Status | Indications (approved or requested) | Other relevant information |
|---|---|---|---|---|
| EU - centralised procedure | 1 June 20xx | Pending | [details] | |
| USA | 1 June 20xx | Approved Day, month year | [details] |
Applications referred to ACPM
Provide an update on the overseas status of the application in the pre-ACPM response.
Applications not referred to ACPM
Provide an update on the overseas status of the application to the TGA Delegate at the decision phase as defined in the Planning letter.
Module 1.11.2 Foreign product information
When to include foreign product information
Include with all category 1 and category 2 regulatory activities where a similar application has been lodged in:
- New Zealand, Canada and/or United States of America
- European Union via centralised procedure
- the Netherlands, Sweden, and/or United Kingdom via mutual recognition procedure, decentralised procedure, or national marketing authorisation.
How to prepare information about foreign product information
Prepare copies of each of the following documents from the similar overseas application(s):
- product monograph from Canada
- summary of product characteristics (SmPC) from the Netherlands, Sweden and/or United Kingdom (if approved via mutual recognition procedure, decentralised procedure, or national marketing authorisation)
- United Kingdom SmPC (if via centralised procedure)
- data sheet from New Zealand
- prescribing information from United States of America.
Note:
A draft document may be included in this part of the dossier if the overseas SmPC, monograph, or prescribing information has not been approved at the time the application is lodged in Australia.
If the overseas SmPC, monograph, data sheet, or prescribing information is approved after dossier submission in Australia, the documents should be submitted as they become available.
Applications to be referred to ACPM
Provide updated overseas prescribing information documents or SmPC documents as part of a pre-ACPM response.
Applications not referred to ACPM
Provide updated overseas prescribing information documents or SmPC documents to the TGA Delegate at the decision phase as defined in the Planning letter.
Module 1.11.3 Data similarities and differences
When to include information about data similarities and differences
Include with all category 1 and category 2 regulatory activities for which a similar application has been lodged in:
- New Zealand, Canada and/or United States of America
- European Union (if centralised procedure)
- the Netherlands, Sweden, and/or United Kingdom via mutual recognition or decentralised procedure, or national marketing authorisation.
How to prepare information about data similarities and differences
Prepare a summary of the similarities/differences between the data in the Australian submission and the data packages submitted in:
- New Zealand, Canada and/or United States of America
- European Union (if centralised procedure)
- the Netherlands, Sweden, and/or United Kingdom (if mutual recognition, decentralised procedure, or national marketing authorisation).
Identify and account for any significant differences.
Note:
Category 2 regulatory activities may be rejected if any significant or substantial undisclosed differences are found by the TGA.
Module 1.11.4 Foreign evaluation reports
When to include foreign evaluation reports
Include for:
- all category 2 regulatory activities
- category 1 regulatory activities for which an overseas evaluation report is available.
How to prepare foreign evaluation reports
Category 1 application:
- obtain copies of independent evaluation reports that are available from the list of acceptable countries where a similar application has been approved
- include complete copies of each evaluation report in Module 1.11.4.
Category 2 application:
- obtain copies of the complete evaluation reports from two acceptable countries where a similar application has been approved
- acceptable countries for the purposes of providing evaluation reports are:
- Canada
- Sweden
- the Netherlands
- United Kingdom
- United States of America
- the two overseas evaluation reports must be independent reports
- the formulation, directions for use and indications for the medicine in the dossier must be identical to those evaluated and approved for marketing in the two countries from which the evaluation reports are provided
- any differences between the data set supplied in the dossier to the TGA and the two acceptable countries must be clearly identified in Module 1.11.3
- include complete copies of all evaluation reports in Module 1.11.4.
Legislation
Regulations 16C and 16D of the Therapeutic Goods Regulations 1990 provide for shorter evaluation timeframes if
- the medicine or variation to the medicine has been approved in two other acceptable countries, and
- the applicant is able to provide the evaluation reports from these countries. These regulatory activities are described as category 2 applications.